Medical device based on bioceramics, its use as a synthetic bone graft and process for the preparation thereof

Abstract

The present invention relates to a medical device manufactured using the additive manufacturing process (3D printing). It is a medical device used preferably as a bone graft composed of a porous structure based on bioceramics based on β-tricalcium phosphate (β-TCP) or hydroxyapatite, which may or not contain nanostructures in its composition, for example: carbon nanostructures (graphene, graphene oxide, reduced graphene oxide, carbon nanotubes, etc.) and, in preferred embodiments, stem cells and polymeric membrane. Also, the present invention relates to the use of this device as a bone graft and the process of preparing this device.

1 - 19 . (canceled) 
     
     
         20 . A medical device capable of being used as a synthetic bone graft, said device being comprised of a synthetic bioceramic comprising a material selected from the group consisting of β-tricalcium phosphate and hydroxyapatite;
 wherein said device is produced by additive manufacturing; 
 wherein said device is porous, and said porosity is planned and distributed according to a specific application; and 
 wherein said device is personalized or has a predefined-shape. 
 
     
     
         21 . The medical device according to  claim 20 , wherein said device further comprises a carbon nanostructure. 
     
     
         22 . The medical device according to  claim 21 , wherein the carbon nanostructure is selected from the group consisting of graphene, graphene oxide, reduced graphene oxide, and carbon nanotubes. 
     
     
         23 . The medical device according to  claim 22 , wherein said device comprises graphene in a concentration that varies from 0.001% to 0.01%. 
     
     
         24 . The medical device according to  claim 20 , wherein said device comprises:
 a) a macropore having a diameter of from 360 μm to 440 μm;   b) a micropore having eexternal surface pores from 0.62 μm to 0.76 μm, and cross-sectional pores from 0.55 μm to 0.67 μm; and   c) a microstructure having a porosity of from 25.0% to 30.0%; an average diameter of from 0.63 to 0.77 μm; a penetration rate of from 0.023 cm 3 /g to 0.029 cm 3 /g, an average density of from 2.892 g/cm 3  to 3.534 g/cm 3 , and 80% of pores: having a size of from 0.39 μm to 5.47 μm.   
     
     
         25 . The medical device according to  claim 20 , wherein said device comprises stem cells: 
     
     
         26 . The medical device according to  claim 25 , wherein the stem cells are autogenous adult mesenchymal stem cells obtained from a dermal punch of a patient. 
     
     
         27 . The medical device according to  claim 20 , wherein the synthetic bioceramic comprises β-tricalcium phosphate (≥95% of β-TCP). 
     
     
         28 . The medical device according to  claim 20 , wherein the synthetic bioceramic comprises hydroxyapatite (≥95% of HA). 
     
     
         29 . The medical device according to  claim 20 , wherein said device is a patient-specific medical device planned and built virtually based on data acquired by computed tomography or magnetic resonance using virtual 3D models and CAD/CAM techniques. 
     
     
         30 . The medical device according to  claim 20 , wherein said device is a predefined-shape medical device that is customized by a surgeon. 
     
     
         31 . The medical device according to  claim 20 , wherein said device comprises internal filling. 
     
     
         32 . The medical device according to  claim 31 , wherein said internal filling has a gyroid shape. 
     
     
         33 . The medical device according to  claim 20 , wherein said device comprises a polydioxanone polymer membrane. 
     
     
         34 . A process for preparing the medical device according to  claim 20 , comprising:
 a. examining a patient's images obtained using CAD software;   b. generating a planning report file in STL format in binary encoding which is sent for approval by a dental surgeon;   c. upon obtaining approval of the planning report file, said file is imported by print preparation software, wherein parameters relating to raw material are added, and said file is sent to a printer via a wireless or cable connection; and   d. said medical device is produced by additive manufacturing based on said planning report file.   
     
     
         35 . The process according to  claim 34 , wherein the patient's images are obtained from computed tomography or a DICOM file. 
     
     
         36 . A process for preparing the medical device according to  claim 20 , comprising:
 a. preparing technical drawings of standard models;   b. preparing an archive of said technical drawings when approved by a technical project team;   c. customizing a graft according to the anatomy of a receiving bed with the aid of drills and sterile surgical/prosthetic discs for straight pieces;   d finishing said device so as to leave no sharp edges and corners to avoid perforation of a flap on the device; and   e. adapting a block to the receiving bed without leaving steps, and leveling all sides said device to prepare a graft for a bone defect.   
     
     
         37 . The process according to  claim 36 , wherein the standard models are a block, a wedge, or a cylinder. 
     
     
         38 . A process for insertion of the medical device according to  claim 20  comprising:
 a. conducting an initial site assessment to check for clinical defects; 
 b. detaching tissue to expose a surgical bed; 
 c. using a polymeric guide to verify insertion of said medical device; 
 d perforating the surgical bed to allow blood perfusion and nutrition of said medical device; and 
 e. adapting said medical device on the surgical bed via screw stabilization. 
 
     
     
         39 . The process according to  claim 38  wherein the polymeric guide is a bone graft analog produced by additive manufacturing. 
     
     
         40 . A method of using the medical device according to  claim 20  comprising using said medical device to function as a bone graft both for volume augmentation/reconstruction of cranio-maxillofacial, neurocranium, long bones and spine defects, and to provide maintenance space wherein said medical device is gradually replaced by newly formed bone. 
     
     
         41 . The method according to  claim 40  wherein said medical device is used for a process selected from the group consisting of bone reconstructions for horizontal and/or vertical augmentation, filling of intraosseous defects; traumatology and bone reconstructions for horizontal and/or vertical augmentation; and filling of intraosseous bone defects.